FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
16CH AI BREAST COILS 1.5 T AND 3 T
K Number: K083255
·
Decision Nov 21, 2008
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
478
Applicant Total
3
Review Days
17
Basic Information
- Device Name
- 16CH AI BREAST COILS 1.5 T AND 3 T
- K Number
- K083255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RAPID BIOMEDICAL GMBH
- Date Received
- November 4, 2008
- Decision Date
- November 21, 2008
- Product Code
- MOS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MOS), ordered by most recent decision date.
16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
FDA 510(k)
FDA Class 2
·Radiology
InkSpace Imaging Small Body Array
FDA 510(k)
FDA Class 2
·Radiology
XENOVIEW 3.0T Chest Coil
FDA 510(k)
FDA Class 2
·Radiology
dS Wrist coil 8ch 1.5T
FDA 510(k)
FDA Class 2
·Radiology
dS Knee Coil 8ch 1.5T
FDA 510(k)
FDA Class 2
·Radiology
dS FootAnkle Coil 8ch 1.5T
FDA 510(k)
FDA Class 2
·Radiology